Trial Outcomes & Findings for Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC) (NCT NCT02638090)
NCT ID: NCT02638090
Last Updated: 2025-12-22
Results Overview
The maximum tolerated dose (MTD) corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2025-12-22
Participant Flow
Participant milestones
| Measure |
Phase 1- Dose Level 1
Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks.
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Phase I - Dose Level 2
Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Phase Ib Expansion
Pembrolizumab plus Vorinostat.
Level 1: Maximum Tolerated Dose (MTD)
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm A: Pembrolizumab
Pembrolizumab treatment only.
Level 1: Pembrolizumab 200 mg Q3 wks
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm B: Pembrolizumab Plus Vorinostat
Pembrolizumab plus Vorinostat treatment.
Level 1: MTD
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
20
|
40
|
46
|
|
Overall Study
COMPLETED
|
4
|
9
|
20
|
40
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Phase I - Dose Level 1
n=5 Participants
Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks.
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Phase I - Dose Level 2
n=9 Participants
Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Phase Ib Expansion
n=20 Participants
Pembrolizumab plus Vorinostat.
Level 1: Maximum Tolerated Dose (MTD)
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm A: Pembrolizumab
n=40 Participants
Pembrolizumab treatment only.
Level 1: Pembrolizumab 200 mg Q3 wks
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm B: Pembrolizumab Plus Vorinostat
n=46 Participants
Pembrolizumab plus Vorinostat treatment.
Level 1: MTD
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=18 Participants
|
66 years
n=102 Participants
|
68 years
n=30 Participants
|
69 years
n=37 Participants
|
68 years
n=127 Participants
|
68 years
n=77 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=18 Participants
|
2 Participants
n=102 Participants
|
7 Participants
n=30 Participants
|
16 Participants
n=37 Participants
|
24 Participants
n=127 Participants
|
51 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=18 Participants
|
7 Participants
n=102 Participants
|
13 Participants
n=30 Participants
|
24 Participants
n=37 Participants
|
22 Participants
n=127 Participants
|
69 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=127 Participants
|
3 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=18 Participants
|
8 Participants
n=102 Participants
|
20 Participants
n=30 Participants
|
37 Participants
n=37 Participants
|
43 Participants
n=127 Participants
|
113 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=37 Participants
|
2 Participants
n=127 Participants
|
4 Participants
n=77 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
2 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=18 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=37 Participants
|
4 Participants
n=127 Participants
|
7 Participants
n=77 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=18 Participants
|
8 Participants
n=102 Participants
|
19 Participants
n=30 Participants
|
38 Participants
n=37 Participants
|
41 Participants
n=127 Participants
|
110 Participants
n=77 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=127 Participants
|
1 Participants
n=77 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=18 Participants
|
9 participants
n=102 Participants
|
20 participants
n=30 Participants
|
40 participants
n=37 Participants
|
46 participants
n=127 Participants
|
120 participants
n=77 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsThe maximum tolerated dose (MTD) corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
Outcome measures
| Measure |
Phase I Dose Escalation
n=13 Participants
Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks.
Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm B: Pembrolizumab Plus Vorinostat
Pembrolizumab plus Vorinostat treatment.
Level 1: MTD
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
|---|---|---|
|
Phase I: Maximum Tolerated Dose (MTD)
|
400 Milligrams of Vorinostat
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPFS will be measured from the start of treatment with pembrolizumab and vorinostat until the documentation of disease progression or death due to any cause, whichever occurs first. Progression: One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.
Outcome measures
| Measure |
Phase I Dose Escalation
n=40 Participants
Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks.
Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm B: Pembrolizumab Plus Vorinostat
n=46 Participants
Pembrolizumab plus Vorinostat treatment.
Level 1: MTD
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
|---|---|---|
|
Phase II: Progression Free Survival (PFS) Per Treatment Arm
|
4.5 Months
Interval 2.1 to 9.3
|
4.3 Months
Interval 2.8 to 9.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsComplete response (CR) or partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1. The ORR will be estimated by calculating the proportion of participants who achieve OR; the 80% confidence interval (CI) and 95% CI for the OR rate will be estimated using the exact binomial distribution. CR: Complete disappearance of all target and non-target lesions (exception: lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (target or non-target) must have reduction in short axis to \< 1.0 cm. All disease must be assessed using the same technique as baseline. PR: Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.
Outcome measures
| Measure |
Phase I Dose Escalation
n=40 Participants
Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks.
Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm B: Pembrolizumab Plus Vorinostat
n=43 Participants
Pembrolizumab plus Vorinostat treatment.
Level 1: MTD
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
|---|---|---|
|
Phase II: Objective Response Rate (ORR) Per Treatment Arm
|
28 Percentage of Participants with OR
|
41 Percentage of Participants with OR
|
Adverse Events
Phase I Dose Escalation - Level 1
Serious events: 4 serious events
Other events: 5 other events
Deaths: 5 deaths
Phase I Dose Escalation - Level 2
Serious events: 3 serious events
Other events: 8 other events
Deaths: 9 deaths
Phase Ib Expansion
Serious events: 14 serious events
Other events: 20 other events
Deaths: 18 deaths
Arm A: Pembrolizumab
Serious events: 16 serious events
Other events: 40 other events
Deaths: 35 deaths
Arm B: Pembrolizumab Plus Vorinostat
Serious events: 26 serious events
Other events: 45 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Phase I Dose Escalation - Level 1
n=5 participants at risk
Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks.
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Phase I Dose Escalation - Level 2
n=9 participants at risk
Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Phase Ib Expansion
n=20 participants at risk
Pembrolizumab plus Vorinostat.
Level 1: Maximum Tolerated Dose (MTD)
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm A: Pembrolizumab
n=40 participants at risk
Pembrolizumab treatment only.
Level 1: Pembrolizumab 200 mg Q3 wks
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm B: Pembrolizumab Plus Vorinostat
n=46 participants at risk
Pembrolizumab plus Vorinostat treatment.
Level 1: MTD
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
20.0%
4/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Fatigue
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Fever
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.2%
2/9 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
8.7%
4/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
8.7%
4/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
40.0%
2/5 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Death NOS
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Alcohol intolerance
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Localized edema
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
3/20 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Non-cardiac chest pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
Other adverse events
| Measure |
Phase I Dose Escalation - Level 1
n=5 participants at risk
Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks.
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Phase I Dose Escalation - Level 2
n=9 participants at risk
Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Phase Ib Expansion
n=20 participants at risk
Pembrolizumab plus Vorinostat.
Level 1: Maximum Tolerated Dose (MTD)
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm A: Pembrolizumab
n=40 participants at risk
Pembrolizumab treatment only.
Level 1: Pembrolizumab 200 mg Q3 wks
Pembrolizumab: Administered per treatment arm guidelines.
|
Arm B: Pembrolizumab Plus Vorinostat
n=46 participants at risk
Pembrolizumab plus Vorinostat treatment.
Level 1: MTD
Vorinostat: Administered per treatment arm guidelines.
Pembrolizumab: Administered per treatment arm guidelines.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Localized edema
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Gait disturbance
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Edema face
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Edema trunk
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Infusion related reaction
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Infusion site extravasation
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Malaise
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.2%
2/9 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
30.0%
6/20 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
32.5%
13/40 • Number of events 14 • All adverse events are recorded from C1D1 and for up to 2 years
|
23.9%
11/46 • Number of events 13 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
3/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.5%
9/40 • Number of events 9 • All adverse events are recorded from C1D1 and for up to 2 years
|
17.4%
8/46 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
3/20 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.5%
9/40 • Number of events 14 • All adverse events are recorded from C1D1 and for up to 2 years
|
13.0%
6/46 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
3/5 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.2%
2/9 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
40.0%
8/20 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
17.5%
7/40 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
37.0%
17/46 • Number of events 22 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
17.4%
8/46 • Number of events 17 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
25.0%
5/20 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
19.6%
9/46 • Number of events 14 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
8.7%
4/46 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Alcohol intolerance
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Creatinine increased
|
20.0%
1/5 • Number of events 17 • All adverse events are recorded from C1D1 and for up to 2 years
|
55.6%
5/9 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
35.0%
7/20 • Number of events 13 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
26.1%
12/46 • Number of events 20 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Weight loss
|
40.0%
2/5 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
25.0%
5/20 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
8.7%
4/46 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
25.0%
5/20 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
8.7%
4/46 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
25.0%
5/20 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
20.0%
4/20 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
20.0%
4/20 • Number of events 9 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
6/40 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
17.4%
8/46 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
25.0%
5/20 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
6/40 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.9%
5/46 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.2%
2/9 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Skin infection
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Paronychia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.2%
2/9 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
17.4%
8/46 • Number of events 9 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
13.0%
6/46 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
33.3%
3/9 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
30.0%
6/20 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
19.6%
9/46 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
13.0%
6/46 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
13.0%
6/46 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
13.0%
6/46 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
3/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.2%
7/46 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
12.5%
5/40 • Number of events 11 • All adverse events are recorded from C1D1 and for up to 2 years
|
13.0%
6/46 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
6/40 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
44.4%
4/9 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
35.0%
7/20 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
6/40 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
19.6%
9/46 • Number of events 18 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
3/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
12.5%
5/40 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.2%
2/9 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
3/20 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Eye disorders
Uveitis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Death
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
66.7%
6/9 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
45.0%
9/20 • Number of events 13 • All adverse events are recorded from C1D1 and for up to 2 years
|
25.0%
10/40 • Number of events 11 • All adverse events are recorded from C1D1 and for up to 2 years
|
45.7%
21/46 • Number of events 30 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
33.3%
3/9 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
40.0%
8/20 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
32.5%
13/40 • Number of events 17 • All adverse events are recorded from C1D1 and for up to 2 years
|
21.7%
10/46 • Number of events 17 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Fever
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.2%
2/9 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
25.0%
5/20 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
13.0%
6/46 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.2%
7/46 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
20.0%
4/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
3/20 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
8.7%
4/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
2/20 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
General disorders
Chills
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.2%
2/9 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
35.0%
7/20 • Number of events 12 • All adverse events are recorded from C1D1 and for up to 2 years
|
20.0%
8/40 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
58.7%
27/46 • Number of events 32 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
40.0%
8/20 • Number of events 10 • All adverse events are recorded from C1D1 and for up to 2 years
|
12.5%
5/40 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
52.2%
24/46 • Number of events 32 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
80.0%
4/5 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
45.0%
9/20 • Number of events 9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
26.1%
12/46 • Number of events 14 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
30.0%
6/20 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
12.5%
5/40 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
13.0%
6/46 • Number of events 7 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
6/40 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.2%
7/46 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
13.0%
6/46 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
20.0%
4/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
15.0%
3/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.9%
5/46 • Number of events 8 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
21.7%
10/46 • Number of events 16 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
7.5%
3/40 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.0%
4/40 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.9%
5/46 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
20.0%
1/5 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
22.2%
2/9 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
6.5%
3/46 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
4.3%
2/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
33.3%
3/9 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
20.0%
4/20 • Number of events 4 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
2/40 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.9%
5/46 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Vascular disorders
Hypotension
|
40.0%
2/5 • Number of events 2 • All adverse events are recorded from C1D1 and for up to 2 years
|
11.1%
1/9 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
12.5%
5/40 • Number of events 6 • All adverse events are recorded from C1D1 and for up to 2 years
|
10.9%
5/46 • Number of events 5 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 3 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/20 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.5%
1/40 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/46 • All adverse events are recorded from C1D1 and for up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/5 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/9 • All adverse events are recorded from C1D1 and for up to 2 years
|
5.0%
1/20 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
0.00%
0/40 • All adverse events are recorded from C1D1 and for up to 2 years
|
2.2%
1/46 • Number of events 1 • All adverse events are recorded from C1D1 and for up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place